Better coordination in development and review of vaccines is needed.

FDA Prioritizes Process Improvements

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Subunit Vaccines and the Fight Against COVID-19

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Meeting the Demand for Lipid Excipients

Topic

Articles

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

UK Approves First Bivalent COVID-19 Booster Vaccine

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Moderna and European Commission Amend COVID-19 Vaccine Agreement

The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.

The US Purchases 66 Million Doses of Moderna’s COVID-19 Vaccine for $1.74 Billion

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses 

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

First Successful Efficacy Study Against Omicron With COVID-19 Vaccine

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

FDA Authorizes COVID-19 Vaccines for Individuals Six Months and Older

Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.

Moderna Bivalent Booster Candidate Demonstrates Superior Antibody Response Against Omicron

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

COVID-19 Update

FDA Prioritizes Process Improvements

Subunit Vaccines and the Fight Against COVID-19

Meeting the Demand for Lipid Excipients